BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LUMITEX LIGHTMAT

    MDR report key: 2814279 · Received October 16, 2012

    Report

    Report Number
    2814279
    Event Type
    Malfunction
    Date Received
    October 16, 2012
    Date of Event
    September 12, 2012
    Report Date
    October 16, 2012
    Manufacturer
    LUMITEX, INC.
    Product Code
    FDG
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    TX, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    THE FOLLOWING ARE THE MANAGER'S COMMENTS ABOUT THE INCIDENT. "A FIBEROPTIC RETRACTOR CALLED A LIGHT MAT HAS A DISPOSABLE FIBEROPTIC LIGHT THAT ATTACHES TO A NON DISPOSABLE LIGHT CORD. THE DISPOSABLE PORTION IS ATTACHED BY THE CST OR THE SURGEON TO A RETRACTOR AND THE DISTAL END IS ATTACHED TO THE LIGHT MAT CORD. THE CONNECTION BETWEEN THE DISPOSABLE FIBEROPTIC LIGHT AND THE CORD BECAME VERY HOT DURING THIS PROCEDURE AND BECAUSE THAT PORTION WAS DISTAL TO THE ACTUAL RETRACTOR THAT THE SURGEON WAS HOLDING HE WAS NOT AWARE THAT THE METAL CONNECTION HAD BECOME EXCEPTIONALLY HOT. THE SCRUB TECH AND THE SURGEON HAD PROTECTED THE PATIENT'S SKIN WITH TOWELS AND DRAPES AND TAKEN CARE NOT TO LAY THE RETRACTOR ON THE PATIENT'S SKIN. HOWEVER AT THE END OF THE PROCEDURE SEVERAL RED BLISTERS WERE NOTED ON THE PATIENT'S RIGHT BREAST. UPON INVESTIGATION THE CST AND THE SURGEON FOUND THAT THE METAL CONNECTION BETWEEN THE LIGHT CORD AND THE FIBEROPTIC LIGHT WAS EXCEPTIONALLY HOT AND REALIZED THAT THIS PORTION OF THE LIGHT MAT MUST HAVE TOUCHED THE PATIENT'S SKIN WHILE THE SURGEON WAS USING THE LIGHT MAT TO RETRACT. THE SURGEON AND THE CST HAD PROTECTED THE PATIENT'S SKIN FROM THE ACTUAL LIGHT END OF THE RETRACTOR BUT THEY DID NOT REALIZE THAT THE DISTAL METAL CONNECTION WAS HOT ENOUGH TO BURN THE PATIENT'S SKIN. THIS METAL PORTION SHOULD NOT BE HOT ENOUGH TO CAUSE A BLISTER TO THE SKIN AND THE SURGEON AND THE CST REPORTED THAT THE LIGHT MAT NEEDED TO BE INSPECTED FOR THE CAUSE OF THE OVERHEATING. THE LIGHT CORD WAS GIVEN TO THE MATERIAL MANAGER WHO CALLED THE REP. THE REP PICKED UP THE LIGHT CORD AND SENT IT TO THE COMPANY TO BE CHECKED OUT. THE LITERATURE THAT COMES FROM THE MANUFACTURER SAYS THE LIGHT MAT IS TO BE USED WITH A STANDARD 300 WATT XENON LIGHT SOURCE WHICH IS WHAT WAS USED FOR THE CASE. THE REP'S SOLUTION WAS A PLASTIC CAGE WHICH FITS OVER THE METAL PORTION OF THE LIGHT CORD TO PROTECT THE PATIENT FROM THE HOT METAL. HE BROUGHT US THIS DEVICE CALLED A CABLE BUDDY AFTER THE INCIDENT. HE HAD NEVER SHOWED US THIS DEVICE BEFORE THE INCIDENT AND WE HAVE USED THE LIGHT MAT PRODUCT FOR AT LEAST 3 YEARS NOW."

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LUMITEX LIGHTMAT RETRACTOR, FIBEROPTIC FDG LUMITEX, INC. 005011 *

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR